Apparatus and method for implanting an implantable device

ABSTRACT

In various examples, an apparatus is configured for subcutaneously inserting an implantable device within a patient. The apparatus includes a dilator portion including a dilator including a dilator length. The dilator portion is configured to separate tissue to create a subcutaneous pocket within the patient sized and shaped to accommodate an implantable device within the subcutaneous pocket. A sheath portion includes a sheath sized and shaped to accommodate the dilator within a sheath lumen. The sheath is configured to accommodate an antenna of the implantable device with the dilator removed from within the sheath. The sheath includes a sheath length that is at least substantially as long as an antenna length. The sheath is configured to separate to allow removal of the sheath around the implantable device to remove the sheath from and leave the implantable device within the subcutaneous pocket within the patient.

TECHNICAL FIELD

The present patent document pertains generally to an insertion tool andmore particularly, but not by way of limitation, to an insertion toolfor subcutaneous placement of an implantable medical device.

BACKGROUND

Implantable devices that monitor cardiac physiologic activity arefrequently implanted subcutaneously under a patient's skin in the chest.An implantable loop recorder (ILR) is an example of a device that may beimplanted in this fashion.

To implant an ILR device with a flexible lead or antenna, an incision ismade, a subcutaneous pocket is formed near the incision, and a tunnel isformed to extend away from the pocket for placement of the flexible leadusing a surgical tool, such as forceps or scissors, or a finger. The ILRdevice can be inserted through the incision and placed in thesubcutaneous pocket, tested for proper operation, and repositioned ifnecessary. The incision is then closed.

Implanting such ILR devices with flexible components in this manner maybe difficult, especially for physicians who are not skilled in deviceimplantation. If the ILR device is improperly implanted, undesirablecomplications for the patient, such as prolonged healing time, orsuboptimal device performance may result. In addition, tearing of tissueduring formation of the pocket and tunnel, for example, may result intissue bleeding that requires appropriate steps during surgery to avoidhematoma. In addition, it may be necessary to employ fluoroscopy toassure that the antenna is properly positioned under the skin. If notproperly positioned, the ILR and antenna may require repositioning toobtain an optimal ECG signal. This can extend the surgery duration,which can increase risk of infection and trauma, as well as expense.

Overview

This overview is intended to provide an overview of subject matter ofthe present patent application. It is not intended to provide anexclusive or exhaustive explanation of the invention. The detaileddescription is included to provide further information about the presentpatent application.

The present inventors have recognized, among other things, that thepresent subject matter can be used to subcutaneously implant a device.The present inventors have further recognized, among other things, thatthe present subject matter, in various examples, can provide a simplerapproach to insertion, shorter insertion time, reduced risk ofcomplications, reduced expense, and/or a reduced need for expensiveequipment, such as fluoroscopy, during device placement. To betterillustrate the apparatuses and methods described herein, a non-limitinglist of examples is provided here:

Example 1 can include subject matter that can include an apparatus forsubcutaneously inserting an implantable device within a patient. Theimplantable device includes a housing and an antenna. The antennaincludes an antenna length. The apparatus includes a dilator portionincluding a dilator including a dilator length. The dilator portion isconfigured to separate tissue to create a subcutaneous pocket within thepatient sized and shaped to accommodate the implantable device withinthe subcutaneous pocket. A sheath portion includes a sheath sized andshaped to accommodate the dilator within a sheath lumen. The sheath isconfigured to accommodate the antenna of the implantable device with thedilator removed from within the sheath, wherein the sheath includes asheath length that is at least substantially as long as the antennalength. The sheath is configured to separate to allow removal of thesheath around the implantable device to remove the sheath from and leavethe implantable device within the subcutaneous pocket within thepatient.

In Example 2, the subject matter of Example 1 is optionally configuredsuch that the dilator portion includes a handle configured to separatetissue to create the subcutaneous pocket, such that the dilator portionis configured to create a portion of the subcutaneous pocket configuredto accommodate the antenna of the device. The handle is configured tocreate a portion of the subcutaneous pocket configured to accommodatethe housing of the device.

In Example 3, the subject matter of any one of Examples 1-2 isoptionally configured such that the sheath portion includes a sheathhousing at a sheath proximal end, the sheath housing including a passagefluidly coupled with the sheath lumen.

In Example 4, the subject matter of Example 3 is optionally configuredsuch that the dilator portion includes a handle, the handle having aportion complementary to the passage of the sheath housing to fit withinthe passage with the dilator disposed within the sheath.

In Example 5, the subject matter of any one of Examples 3-4 isoptionally configured such that the passage of the sheath housingincludes a funnel shape configured to facilitate insertion of theantenna within the sheath lumen.

In Example 6, the subject matter of any one of Examples 3-5 isoptionally configured such that the sheath housing includes a firstmaterial and the sheath includes a second material, the first materialbeing different than the second material.

In Example 7, the subject matter of any one of Examples 1-6 isoptionally configured such that the dilator includes a distal dilatorend including an atraumatic shape. The dilator length is longer than thesheath length to allow the distal dilator end to extend distally fromthe sheath.

In Example 8, the subject matter of Example 7 is optionally includes atleast two electrodes configured to electrically couple to a test device.The electrodes are configured to verify a signal at a location withinthe patient prior to implantation of the implantable device.

In Example 9, the subject matter of any one of Examples 1-8 isoptionally configured such that the sheath is configured to split withremoval of the sheath over the implantable device.

In Example 10, the subject matter of Example 9 is optionally configuredsuch that the sheath is configured to split substantially longitudinallyalong the sheath.

In Example 11, the subject matter of any one of Examples 1-10 isoptionally configured such that the sheath includes a substantiallylongitudinal split extending from a proximal sheath end to a distalsheath end. The sheath is configured to spread apart along the split toallow removal of the sheath past the housing of the implantable device.

In Example 12, the subject matter of Example 11 is optionally configuredsuch that the sheath includes a first edge and a second edge forming thesubstantially longitudinal split, the first edge being proximate thesecond edge.

In Example 13, the subject matter of Example 12 is optionally configuredsuch that the first edge is separated from the second edge by a gap.

In Example 14, the subject matter of Example 12 is optionally configuredsuch that the first edge abuts the second edge.

In Example 15, the subject matter of Example 12 is optionally configuredsuch that the first edge overlaps the second edge.

Example 16 can include, or can optionally be combined with any one ofExamples 1-15 to include subject matter that can include an apparatusfor subcutaneously inserting an implantable device within a patient. Theimplantable device includes a housing and an antenna. The antennaincludes an antenna length. The apparatus includes a dilator portionincluding a dilator including a dilator length. The dilator portion isconfigured to separate tissue to create a subcutaneous pocket within thepatient sized and shaped to accommodate the implantable device withinthe subcutaneous pocket. A sheath portion includes a sheath is sized andshaped to accommodate the dilator within a sheath lumen. The sheath isconfigured to accommodate the antenna of the implantable device with thedilator removed from within the sheath, wherein the sheath includes asheath length that is at least substantially as long as the antennalength. A sheath housing is disposed at a proximal sheath end. Thesheath housing includes a passage fluidly coupled with the sheath lumenat a sheath housing distal end and extends through the sheath housing toa sheath housing proximal end. The sheath housing includes an opening ina sidewall of the sheath housing, wherein the sheath is configured toseparate along a separation line substantially aligning with the openingin the sidewall of the sheath housing. The separation line and theopening cooperating to allow the housing to pass through the opening andthe separated sheath with removal of the sheath from the implantabledevice to leave the implantable device within the subcutaneous pocketwithin the patient.

In Example 17, the subject matter of Example 16 is optionally configuredsuch that the sheath is configured to split with removal of the sheathover the implantable device.

In Example 18, the subject matter of Example 16 is optionally configuredsuch that the sheath includes a first edge and a second edge forming asubstantially longitudinal split extending from a sheath proximal end toa sheath distal end, wherein the sheath is configured to spread apartalong the split to allow removal of the sheath past the housing of theimplantable device.

In Example 19, the subject matter of Example 18 is optionally configuredsuch that the dilator portion includes a handle configured to separatetissue to create the subcutaneous pocket. The dilator portion isconfigured to create a portion of the subcutaneous pocket configured toaccommodate the antenna of the device. The handle is configured tocreate a portion of the subcutaneous pocket configured to accommodatethe housing of the device.

In Example 20, the subject matter of Example 18 optionally includes atleast two electrodes configured to electrically couple to a test device.The electrodes are configured to verify a signal at a location withinthe patient prior to implantation of the implantable device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an example implantable apparatus that can be implantedwithin a patient in accordance with at least one example of theinvention.

FIGS. 2A-2G show an apparatus for subcutaneously inserting animplantable device within a patient in accordance with at least oneexample of the invention.

FIGS. 3A-3C show an apparatus for subcutaneously inserting animplantable device within a patient in accordance with at least oneexample of the invention.

FIGS. 4A-4D show an apparatus for subcutaneously inserting animplantable device within a patient in accordance with at least oneexample of the invention.

FIGS. 5A-5E show an apparatus for subcutaneously inserting animplantable device within a patient in accordance with at least oneexample of the invention.

FIGS. 6A-6C show an apparatus for subcutaneously inserting animplantable device within a patient in accordance with at least oneexample of the invention.

FIGS. 7A-7C show an apparatus for subcutaneously insulting animplantable device within a patient in accordance with at least oneexample of the invention.

FIGS. 8A-8C show an apparatus for subcutaneously inserting animplantable device within a patient in accordance with at least oneexample of the invention.

FIGS. 9A and 9B each show an apparatus for subcutaneously inserting animplantable device within a patient in accordance with at least oneexample of the invention.

DETAILED DESCRIPTION

The present patent application relates to apparatuses and methods forsubcutaneous placement of an implantable medical device. In someexamples, the present apparatuses and methods can be used for implantinga medical device, such as, but not limited to, an implantable looprecorder (ILR).

The present inventors have recognized, among other things, that thepresent subject matter can be used to subcutaneously implant a device.The present inventors have further recognized, among other things, thatthe present subject matter, in various examples, can provide a simplerapproach to insertion, shorter insertion time, reduced risk ofcomplications, reduced expense, and/or a reduced need for expensiveequipment, such as fluoroscopy, during device placement. It should beunderstood, however, that the subject matter described herein can beused with other implantable medical devices and/or can be used inconjunction with an external device in some examples.

Referring now FIG. 1, an exemplary implantable device 10, such as animplantable loop recorder (ILR), is shown, which can be subcutaneouslyimplanted under a patient's skin. The ILR includes, in some examples, ahousing 12, for instance, for device electronics and/or a battery powersource. In some examples, a header 14 is supported on the housing andincludes conductors connected to the device electronics through one ormore hermetic feedthroughs. An antenna 16, in some examples, supportinga distal electrode 18 extends outwardly from the header 14 and has anantenna length L measured from the header 14 to a distal end 16A of theantenna 16. This device can be used, for instance, to record anelectrocardiogram (ECG) signal for the patient.

In some examples, a first end of the flexible antenna 16 is attached ata fixation point to the header 14, and can generally flex or bend aboutthe fixation point. The header 14 thus stabilizes the flexible antenna16, yet allows it to bend and flex about the fixation point to conformto body tissue channel formation and subsequent tissue movement andflexing as the patient's muscles contract and expand during dailyactivities. In general, the flexible antenna 16 can bend at anyappropriate angle with respect to the fixation point at the header 14,and in any appropriate direction.

The ILR device 10 can house a battery, which may be of a single-use orrechargeable chemistry, and circuitry (e.g., an electronics module) forperforming actions consistent with the device's intended purpose.Without limitation, examples of actions that may be performed with someimplementations of the device include measuring one or more physiologicsignals, storing the measured signal(s) in memory within the device 10,processing collected data, wirelessly transmitting or receivinginformation to/from an external device, and others. In some examples,the housing 12 can include a charging coil that can be excited (e.g.,with an external charging coil placed in proximity to the implantlocation) to recharge a rechargeable battery of the device.

In some examples, using one of the tunneling tools and techniquesdiscussed herein, the ILR 10 can be implanted in a minimally invasivefashion that minimizes an incision size for insertion; minimizes traumato body tissue during formation of a subdermal or subcutaneous channelfor the implantable device 10; minimizes risk of puncture or intrusionupon a muscle layer, intercostal space, or body organ; and provides afitted implant location closely tailored to actual device dimensions.Because incision size can be reduced as compared to previous implanttechniques, a scar from the insertion may be less noticeable. Also, byforming an appropriately sized pocket for the implantable device 10, arisk of hematoma can be reduced. Further, the devices, systems, andtechniques disclosed herein can significantly reduce the time requiredfor implantation, and can mitigate the need for fluoroscopy, therebyreducing the cost associated with the implantation procedure. Moreover,the simplicity of the approach described here can make implantationfeasible in a procedure room or doctor's office, and can provide forconsistently safe and effective results when implanted by physicians wholack experience and skills in placing implantable devices. For at leastthese reasons, physicians may prefer the systems, devices, andtechniques discussed herein when compared to presently available implantmethods and devices.

By way of example, the device 10, in some examples, can be a minimallyinvasive implantable monitoring device that senses and records aphysiologic parameter, such as electrical activity of the heart, withina body of a patient. In some examples, the device 10 can include animplantable monitoring device that senses and records a physiologicparameter, such as an electrocardiogram (ECG) signal, within the body ofthe patient and wirelessly transmits information associated with thephysiologic parameter to an external device. Such a monitoring-onlydevice that records cardiac electrical information can be implanted in ahuman patient for a relatively short period of time, such as a fewmonths, for example. Other physiologic parameters or combinations ofparameters, such as other electrical signals (e.g., EEG signal, EMGneural signal, bio-impedance signal), mechanical signals (e.g., bloodpressure signal, blood flow signal), chemical signals (e.g., glucose),temperature, and the like can similarly be recorded by the device 10 invarious examples.

In some examples, the device 10 can be relatively small and can be sizedand shaped for convenient implantation within a body of a patient, suchas at a subcutaneous implant site, for example, in a pectoral region ofa human patient. A tunneling tool according to the present invention maybe used to directly insert the ILR 10 to a subcutaneous implantlocation.

In some examples, the ILR device 10 can include one or more electrodesfor electrically interfacing to surrounding tissue for the purpose ofsensing electrical activity. In some examples, the device 10 includestwo electrodes. For example, FIG. 1 shows an implantable device with anexterior surface of the housing 12 providing a proximal electrode 12A. Adistal electrode 18 is located proximate the distal end 16A of theantenna 16. The implantable device, in some examples, can be programmedto measure a potential difference (e.g., a subcutaneous ECG signal)between the proximal and distal electrodes 12A, 18. The electrodes 12A,18 are each near a longitudinal end of the device 10. This placement canmaximize signal vector length of a measured physiologic signal. Ingeneral, measured amplitude of a sensed physiologic signal, such as anECU signal, will vary with device placement and orientation within thepatient. Sensed signal amplitude can also be related to separationdistance between the measuring electrodes. Positioning the electrodes12A, 18 near opposite ends of the device 10 can maximize the amplitudeof the sensed physiologic signal for a given device length, which canlead to better measurement results. In other implementations, device 10includes three or more electrodes.

In some examples, one of the electrodes can include an excitationelectrode or combination excitation/sense electrodes. As an example, thedevice can measure a bio-impedance for diagnostic purposes by injectinga known current between the electrodes and measuring a resulting voltagethere between two electrodes. In some examples, the electrodes caninclude a conductive material such as titanium.

Referring to FIGS. 2A-2G, in some examples, an apparatus 200 isconfigured for aiding in the subcutaneous implantation within a patientof a device, such as, but not limited to a medical device. In someexamples, the apparatus 200 is configured to create a subcutaneouspocket or other space within the patient in order to implant a device,such as the device 10, within the patient. In some examples, theapparatus 200 can be used to assist in implantation of a device, such asthe device 10.

In some examples, the apparatus 200 is configured to aid in implantationof an implantable device, such as the device 10. In some examples, theapparatus 200 includes a dilator portion 210 and a sheath portion 240.In some examples, the dilator portion 210 includes a dilator 212terminating at a distal dilator end 212A. In some examples, the distaldilator end 212A includes an atraumatic tip or is otherwise shapedand/or configured to minimize tissue damage or other unwanted effects ofusing the apparatus 200 to create a subcutaneous pocket or channel inwhich to implant a device, such as the device 10. In some examples, thedilator portion 210 includes a handle 214 from which the dilator 212extends. The dilator 212 includes a dilator length D. In some examples,the dilator portion 210 includes any polymer including, but not limitedto, one or more of high density polyethylene, nylon, polypropylene, orthe like. In some examples, the dilator portion 210 can include anymetal including, but not limited to, one or more of titanium, stainlesssteel, gold, silver, or any other biologically safe and inert metal. Insome examples, the dilator portion 210 includes more than one material,such as a combination of two or more polymers, a combination of two ormore metals, or a combination of one or more polymers and one or moremetals. In some examples, the dilator portion 210 includes a flexible orpliable material, for instance, to allow at least a portion of thedilator 212 to be shaped, bent, or otherwise configured to contour bodygeometry of the patient. Such a flexible dilator 212, in some examples,can allow for the apparatus 200 to faithfully adhere to anatomical needsand/or specifics of the patient in formation of the subdermal orsubcutaneous pocket or channel for positioning of the device 10.

In some examples, the sheath portion 240 includes a sheath 242 sized andshaped to accommodate the dilator 212 within a sheath lumen 243. In someexamples, the sheath 242 is configured to accommodate the antenna 16 ofthe implantable device 10 with the dilator 212 removed from within thesheath 242. In some examples, the sheath 242 includes a sheath length Sthat is at least substantially as long as the antenna length L. In someexamples, the sheath 242 is configured to separate to allow removal ofthe sheath 242 around the implantable device 10 to remove the sheath 242from and leave the implantable device 10 within the patient. In someexamples, the sheath portion 240 includes a sheath housing 244 at asheath proximal end 240A. The sheath housing 244, in some examples,includes a first material and the sheath 242 includes a second material.In some examples, the first material is more rigid than the secondmaterial. In other examples, the first material and the second materialinclude substantially the same rigidity. In further examples, the sheathhousing 244 and the sheath 242 are formed from the same material. Insome examples, the first material can include any polymer including, butnot limited to, one or more of high density polyethylene, nylon,polypropylene, or the like. In some examples, the first material caninclude any metal including, but not limited to, one or more oftitanium, stainless steel, gold, silver, or any other biologically safeand inert metal. In some examples, the sheath housing 244 includes morethan one material, such as a combination of two or more polymers, acombination of two or more metals, or a combination of one or morepolymers and one or more metals. In some examples, the second materialcan include various polymers including, but not limited to, one or moreof polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP),perfluoroalkoxy (PFA), or the like. In some examples, the sheath 242includes more than one material, such as a combination of two or morepolymers. In some examples, the sheath 242 can include a combination ofmaterials combined in a way to confer properties to the sheath 242 to beadvantageous for the particular use of the apparatus 200. For instance,in some examples, a material can be used for a dorsal side of the sheath242 to facilitate blunt force tissue dissection, and another materialcan be used for a ventral side of the sheath 242 to increase localizedsuppleness for facilitating material slitting, for instance, whenadvancing the device 10 through the sheath 242. It is noted that thematerials listed for the sheath 242 and the sheath housing 244 aremerely exemplary and that other materials or combinations of materialsnot specifically listed are contemplated herein.

In some examples, the sheath housing 244 includes a passage 244C fluidlycoupled with the sheath lumen 243. The passage 244C, in some examples,is fluidly coupled with the sheath lumen 243 at a sheath housing distalend 244B and extends through the sheath housing 244 from the sheathhousing distal end 244B to a sheath housing proximal end 244A. In someexamples, the passage 244C of the sheath housing 244 includes achannel-like configuration. In some examples, the channel-likeconfiguration of the sheath housing 244 allows access to the passage244C along one side of the sheath housing 244, as well as at either endof the sheath housing 244. In some examples, the sheath housing 244 isgenerally U-shaped, horseshoe-shaped, or the like when viewed fromeither end. That is, in some examples, the sheath housing 244 includesan opening in a sidewall of the sheath housing 244. In some examples,the sheath 242 is configured to separate along a separation linesubstantially aligning with the opening in the sidewall of the sheathhousing 244. In some examples, the separation line and the openingcooperate to allow the housing 12 to pass through the opening and theseparated sheath 242 with removal of the sheath 242 from the implantabledevice 10.

In some examples, the dilator portion 210 and the sheath portion 240 areconfigured such that the dilator portion 210 and the sheath portion 240selectively couple together, as shown in FIG. 2A. In some examples, thehandle 214 includes a portion complementary to the passage 244C of thesheath housing 244 to fit within the passage 244C with the dilator 212disposed within the sheath 242. In some examples, the dilator portion210 and the sheath portion 240 are frictionally coupled together, suchthat the dilator portion 210 and the sheath portion 240 can beselectively uncoupled by a physician or other caregiver using theapparatus 200. In some examples, the dilator portion 210 and the sheathportion 240 include a detent or the like to inhibit unexpecteduncoupling of the dilator portion 210 and the sheath portion 240.

In some examples, with the dilator portion 210 and the sheath portion240 coupled together, the distal dilator end 212A of the dilator 212extends distally from the sheath 242. In some examples, the distaldilator end 212A includes an atraumatic shape to allow for tunneling orotherwise inserting the apparatus 200 within the patient with little tono tissue damage or other trauma. That is, in some examples, the dilatorlength D is longer than the sheath length S. In some examples, thedilator length D is longer than the sheath length S to allow the distaldilator end 212A to extend distally from the sheath 242. In someexamples, the dilator 212 and the distal dilator end 212A facilitatetissue separation, tunneling, and/or placement of the apparatus 200within and with respect to a patient. Once the apparatus 200 ispositioned with respect to the patient, the dilator portion 210 can beremoved from the sheath portion 240, leaving the sheath portion 240 inplace with respect to the patient, as shown in FIG. 2B.

With the sheath portion 240 in place with respect to the patient, insome examples, an object, such as, for instance, the implantable device10, can be passed through the sheath portion 240 to implant or partiallyimplant the implantable device 10 or other object within the patient. Insome examples, the antenna 16 can be passed through the passage 244C ofthe sheath housing 244 and into the sheath lumen 243. In some examples,the sheath housing 244 and/or the passage 244C of the sheath housing 244includes a tapered or funnel-like configuration to facilitate insertionof the antenna 16 within the passage 244C and the sheath 242. In someexamples, the passage 244C of the sheath housing 244 includes a funnelshape configured to facilitate insertion of the antenna 16 within thesheath lumen 243. In some examples, the sheath 242 creates a tunnelwithin the patient to allow placement of the antenna 16 within thepatient without resistance or with decreased resistance, for instance,from tissue of the patient through and/or within which the implantabledevice 10 is being implanted. In this way, kinking, bending, or othermisshaping of the antenna 16 can be minimized if not eliminated, whichcan lead to improved performance of the implantable device 10.

Because, in some examples, the housing 12 and/or the header 14 of theimplantable device 10 is larger than the sheath lumen 243, the sheath242 is configured to allow removal of the sheath 242 from within thepatient and past the housing 12. In some examples, referring to FIGS.2C, 2D, and 2G, the sheath 242 is splittable. In some examples, thesheath 242 is configured to split with removal of the sheath 242 overthe implantable device 10. That is, in some examples, the sheath 242 isconfigured to split, rip, or otherwise separate from a proximal sheathend 242A to a distal sheath end 242B to allow the sheath portion 240 tobe removed proximally from the patient around the housing 12 of theimplantable device 10. In some examples, the sheath 242 is configured tosplit substantially longitudinally along the sheath 242.

In some examples, referring specifically to FIG. 2G, the sheath 242includes one or more score lines 242A to facilitate separation of thesheath 242. Although shown in FIG. 2G with only one score line 242A, itis contemplated that the sheath 242 includes more than one score line242A. In some examples, the sheath includes two diametrically opposedscore lines to facilitate the sheath splitting in half. In otherexamples, the sheath includes more than two score lines.

In some examples, the one or more score lines 242A are formed on aninside surface of the sheath 242, as shown in FIG. 2G. In otherexamples, the one or more score lines are formed on an outside surfaceof the sheath. In still other examples, the one or more score lines areformed on both an inside surface and an outside surface of the sheath.

In some examples, the one or more score lines 242A include anotch-shaped or v-shaped cut in the sheath 242. In some examples, theone or more score lines include a rounded cut in the sheath. In variousexamples, the one or more score lines include a thinned portion of thesheath to facilitate splitting of the sheath, along the one or morescore lines. In some examples, the one or more score lines include aline of discrete thinned sections forming one or more perforated scorelines.

In some examples, the one or more thinned areas or score lines 242A aremechanically formed in the sheath 242 using a cutting device, such as,but not limited to one or more of a stationary blade, an oscillatingblade, a rotary cutter, a fluid cutter, a laser cutter, or the like. Insome examples, the one or more thinned areas or score lines 242A arecrimped into the sheath 242. In some examples, the one or more thinnedareas or score lines 242A are molded in the sheath 242. In someexamples, the one or more thinned areas or score lines 242A are formedin the sheath 242 through extrusion. Although several examples offorming the one or more thinned areas or score lines 242A are describedherein, it should be understood that other ways of forming the one ormore thinned areas or score lines 242A are contemplated herein.

In further examples, referring to FIG. 2E, sheath 242′ is presplit. Itshould be understood that, in some examples, the apparatus 200 caninclude the presplit sheath 242′ instead of the splittable sheath 242described above. In some examples, the sheath 242′ includes asubstantially longitudinal split 241′ extending from a sheath proximalend to a sheath distal end. In some examples, the sheath 242′ isconfigured to spread apart along the split 241′ to allow removal of thesheath 242′ past the housing 12 of the implantable device 10. In someexamples, the sheath 242′ includes a first edge 242A′ and a second edge242B′ forming the substantially longitudinal split 241′, the first edge242A′ being proximate the second edge 242B′. In some examples, the firstedge 242A′ is separated from the second edge 242B′ by a gap X. In otherexamples, the first edge 242A′ abuts the second edge 242B′. In eithercase, the split 241′ allows the sheath 242′ to be removed from withinthe patient with at least a portion of the implantable device 10extending out from within a lumen 243′ of the sheath 242′.

In still other examples, referring to FIG. 2F, sheath 242″ is presplit.It should be understood that, in some examples, the apparatus 200 caninclude the presplit sheath 242″ instead of the splittable sheath 242 orthe presplit sheath 242′ described above. In some examples, the sheath242″ includes a substantially longitudinal split 241″ extending from asheath proximal end to a sheath distal end. In some examples, the sheath242″ is configured to spread apart along the split 241″ to allow removalof the sheath 242″ past the housing 12 of the implantable device 10. Insome examples, the sheath 242″ includes a first edge 242A″ and a secondedge 242B″ forming the substantially longitudinal split 241″, the firstedge 242A″ being proximate the second edge 242B″. In some examples, thefirst edge 242A″ overlaps the second edge 242B″. In this way, the split241″ allows the sheath 242″ to be removed from within the patient withat least a portion of the implantable device 10 extending out fromwithin a lumen 243″ of the sheath 242″.

Still referring to FIGS. 2A-2G, in use, in some examples, the apparatus200 (FIG. 2A) is used to create a pocket within the patient forplacement of the device 10 within the patient. Once the pocket iscreated, in some examples, the dilator portion 210 is removed from thesheath portion 240 (FIG. 2B), leaving the sheath portion 240 in placewithin the patient. In some examples, the device 10 can then be at leastpartially placed within the sheath 242, 242′, 242″. For instance, insome examples, the antenna 16 of the device 10 can be inserted withinthe passage 244C and advanced into the lumen 243, 243′, 243″ of thesheath 242, 242′, 242″ (FIG. 2C). The sheath portion 240, in someexamples, can then be pulled proximally out of the patient, around thehousing 12 and the header 14 of the device 10 to remove the sheathportion 240 from within the patient while leaving the device 10 in placewithin the patient. In some examples, the sheath 242 is splittable (FIG.2D or 2G) such that the sheath 242 splits, tears, or otherwise separatesalong a separation line with movement of the sheath 242 past the header14 and/or the housing 12 of the device 10. In other examples, the sheath242′, 242″ is presplit (FIGS. 2E and 2F) such that the sheath 242′, 242″can be passed by the header 14 and/or the housing 12 of the device 10during removal of the sheath portion 240 with the header 14 and/or thehousing 12 of the device 10 passing through the split 241′, 241″ of thesheath 242′, 242″. In this way, the apparatus 200 can be used to createthe pocket within the patient and assist in placing the device 10 withinthe patient. By creating the pocket and inserting the antenna 16 of thedevice using the sheath 242, 242′, 242″, the likelihood of the antenna16 kinking, bending, or folding is decreased over insertion of thedevice 10 without the use of the apparatus 200.

Referring to FIGS. 3A-3C, an apparatus 300 similar to the apparatus 200is configured for aiding in the subcutaneous implantation within apatient of a device, such as, but not limited to a medical device. Insome examples, the apparatus 300 is configured to create a subcutaneouspocket or other space within the patient in order to implant a device,such as the device 10, within the patient. In some examples, theapparatus 300 can be used to assist in implantation of a device, such asthe device 10.

In some examples, the apparatus 300 includes a dilator portion 310 and asheath portion 340. The dilator portion 310 and the sheath portion 340,in some examples, are configured such that the dilator portion 310 andthe sheath portion 340 selectively couple together, as shown in FIG. 3A.In some examples, a handle 314 includes a portion complementary to apassage (for instance, similar to the passage 244C shown and describedherein) of a sheath housing 344 to fit within the passage with a dilator312 disposed within a sheath 342. In some examples, the sheath housing344 and/or the passage of the sheath housing 344 includes a funnel-likeconfiguration to facilitate insertion of the antenna 16 within thepassage and the sheath 342. In some examples, the passage of the sheathhousing 344 includes a funnel shape configured to facilitate insertionof the antenna 16 within a sheath lumen.

In some examples, the dilator portion 310 and the sheath portion 340 arefrictionally coupled together, such that the dilator portion 310 and thesheath portion 340 can be selectively uncoupled by a physician or othercaregiver using the apparatus 300. In some examples, the dilator portion310 and the sheath portion 340 include a detent or the like to inhibitunexpected uncoupling of the dilator portion 310 and the sheath portion340.

In some examples, the dilator 312 terminates at a distal dilator end312A. In some examples, the distal dilator end 312A includes anatraumatic tip or is otherwise shaped and/or configured to minimizetissue damage or other unwanted effects of using the apparatus 300 tocreate a subcutaneous pocket in which to implant a device, such as thedevice 10. In some examples, the dilator 312 is sized to extend distallyfrom the sheath 342 with the dilator portion 310 and the sheath portion340 coupled together.

In some examples, the sheath 342 is presplit. It should be understoodthat, in some examples, the apparatus 300 can include the presplitsheath 342 or a splittable sheath similar to the splittable sheath 242described and shown herein. In some examples, the sheath 342 includes asubstantially longitudinal split 341 extending from a sheath proximalend to a sheath distal end. In some examples, the sheath 342 isconfigured to spread apart along the split 341 to allow removal of thesheath 342 past the housing 12 of the implantable device 10, as shown inFIG. 3C. In some examples, the sheath 342 is separated along thelongitudinal split 341 by the header 14 and/or the housing 12 of thedevice 10 to allow removal of the sheath portion 340 from the patientwhile maintaining the device 10 in place within the patient. That is,the split 341 allows the sheath 342 to be removed from within thepatient with at least a portion of the implantable device 10 extendingout from within the lumen of the sheath 342. In various examples, thepresplit sheath 342 can include a longitudinal split 341 formed byabutting edges, separated edges, or overlapping edges, similar to theexamples described and shown herein with respect to the apparatus 200.

Still referring to FIGS. 3A-3C, in use, in some examples, the apparatus300 (FIG. 3A) is used to create a pocket within the patient forplacement of the device 10 within the patient. Once the pocket iscreated, in some examples, the dilator portion 310 is removed from thesheath portion 340 (FIG. 3B), leaving the sheath portion 340 in placewithin the patient. In some examples, the device 10 can then be at leastpartially placed within the sheath 342. For instance, in some examples,the antenna 16 of the device 10 can be inserted within the passage ofthe sheath portion 340 and advanced into the lumen of the sheath 342(FIG. 3C). The sheath portion 340, in some examples, can then be pulledproximally out of the patient, around the housing 12 and the header 14of the device 10 to remove the sheath portion 340 from within thepatient while leaving the device 10 in place within the patient. In someexamples, the sheath 342 is presplit such that the sheath 342 can bepassed by the header 14 and/or the housing 12 of the device 10 duringremoval of the sheath portion 340 with the header 14 and/or the housing12 of the device 10 passing through the split 341 of the sheath 342. Inthis way, the apparatus 300 can be used to create the pocket within thepatient and assist in placing the device 10 within the patient. Bycreating the pocket and inserting the antenna 16 of the device using thesheath 342, the likelihood of the antenna 16 kinking, bending, orfolding is decreased over insertion of the device 10 without the use ofthe apparatus 300.

Referring to FIGS. 4A-4D, in some examples, an apparatus 400 isconfigured for aiding in the subcutaneous implantation within a patientof a device, such as, but not limited to a medical device. In someexamples, the apparatus 400 is configured to create a subcutaneouspocket or other space within the patient in order to implant a device,such as the device 10, within the patient. In some examples, theapparatus 400 can be used to assist in implantation of a device, such asthe device 10.

In some examples, the apparatus 400 includes a dilator portion 410 and asheath portion 440. The dilator portion 410 and the sheath portion 440,in some examples, are configured such that the dilator portion 410 andthe sheath portion 440 selectively couple together, as shown in FIG. 4A.In some examples, a handle 414 of the dilator portion 410 includes aportion complementary to a passage 444C of a sheath housing 444 to fitwithin the passage 444C with a dilator 412 disposed within a sheath 442.In some examples, the sheath 442 is attached to the sheath housing 444.In some examples, the sheath housing 444 and/or the passage 444C of thesheath housing 444 includes a funnel-like configuration to facilitateinsertion of the antenna 16 within the passage and the sheath 442. Insome examples, the passage of the sheath housing 444 includes a funnelshape configured to facilitate insertion of the antenna 16 within asheath lumen. In some examples, the sheath housing 444 includes twohousing portions 444A, 444B that form the passage 444C. In someexamples, the sheath housing 444 can include more than two housingportions. The housing portions 444A, 444B, in some examples, areconfigured to separate, for instance, to allow the sheath portion 440 tobe removed around the housing 12 and/or the header 14 of the device 10,as is described in more detail below.

In some examples, the dilator portion 410 and the sheath portion 440 arefrictionally coupled together, such that the dilator portion 410 and thesheath portion 440 can be selectively uncoupled by a physician or othercaregiver using the apparatus 400. In some examples, the dilator portion410 and the sheath portion 440 include a detent or the like to inhibitunexpected uncoupling of the dilator portion 410 and the sheath portion440.

In some examples, the dilator 412 terminates at a distal dilator end412A. In some examples, the distal dilator end 412A includes anatraumatic tip or is otherwise shaped and/or configured to minimizetissue damage or other unwanted effects of using the apparatus 400 tocreate a subcutaneous pocket in which to implant a device, such as thedevice 10. In some examples, the dilator 412 is sized to extend distallyfrom the sheath 442 with the dilator portion 410 and the sheath portion440 coupled together.

In some examples, the sheath 442 is splittable. It should be understoodthat, in some examples, the apparatus 400 can include the splittablesheath 442 (similar to the splittable sheathes 242 described and shownherein) or a presplit sheath (similar to the presplit sheathes 242′,242″, 342 described and shown herein). In some examples, once theapparatus 400 is positioned as desired with respect to the patient, thedilator portion 410 is removed (FIG. 4B) and the antenna of the device10 is inserted within the passage 444C (FIG. 4C). When it is desired toremove the sheath portion 440 from within the patient, in some examples,the housing portions 444A, 444B can be separated and the sheath 442 canbe split to allow passage of the sheath housing 444 around the device 10in order to remove the sheath housing 444 from the patient while leavingthe device 10 in place within the patient. In some examples, the housingportions 444A, 444B of the sheath housing 444 are molded together with afrangible connection that can be broken when it is desired to separatethe housing portions 444A, 444B from one another. In some examples, thehousing portions 444A, 444B are frictionally engaged with one another,the housing portions 444A, 444B being able to be disengaged from oneanother by the physician or other caregiver in order to separate thehousing portions 444A, 444B from one another. In some examples, thehousing portions 444A, 444B are engaged with one another using one ormore of a tab-in-slot configuration, a detent configuration, a slidingengagement configuration, or the like. With the housing portions 444A,444B separated, in some examples, the sheath 442 can then be split (FIG.4D) in order to remove the sheath 442 from within the patient whileleaving the device 10 in place within the patient. In some examples, theseparated housing portions 444A, 444B can be pulled apart to split thesheath 442. In some examples, the sheath 442 is attached to proximalends of the housing portions 444A, 444B, as shown in FIG. 4D. In otherexamples, the sheath 442 can be attached to distal ends of the housingportions 444A, 444B or at locations intermediate the proximal ends anddistal ends of the housing portions 444A, 444B. In some examples, thehousing 12 and/or the header 14 of the device 10 is used to split thesheath 442 as the sheath 442 is moved past the housing 12 and the header14 of the device 10, either in addition to or instead of pulling apartof the housing portions 444A, 444B. In some examples, the sheath 442includes a split 441 that extends along the length of the sheath 442with separation of the housing portions 444A, 444B and/or moving of thesheath 442 past the header 14 and/or housing 12 of the device 10. Insome examples, the split 441 propagates from a proximal end of thesheath 442 to a distal end of the sheath 442 to allow the sheath portion440 to be removed from the patient around the device 10 while leavingthe device 10 in place within the patient. In some examples, the sheath442 includes a second split (not visible in FIG. 4D), such that thesheath 442 can be split into two pieces, with one piece attached to onehousing portion 444A and another piece attached to the other housingportion 444B, with removal of the sheath portion 440 around the device10. In other examples, the sheath 442 can be configured to separatealong a single split 441 in order to remove the sheath portion 440 fromwithin the patient.

Referring to FIGS. 5A-5E, in some examples, an apparatus 500 isconfigured for aiding in the subcutaneous implantation within a patientof a device, such as, but not limited to a medical device. In someexamples, the apparatus 500 is configured to create a subcutaneouspocket or other space within the patient in order to implant a device,such as the device 10, within the patient. In some examples, theapparatus 500 can be used to assist in implantation of a device, such asthe device 10.

In some examples, the apparatus 500 includes a dilator portion 510 and asheath portion 540. The dilator portion 510 and the sheath portion 540,in some examples, are configured such that the dilator portion 510 andthe sheath portion 540 selectively couple together, as shown in FIG. 5A.In some examples, a handle 514 includes a portion 518 complementary to apassage 544C of a sheath housing 544 to fit within the passage 544C witha dilator 512 disposed within a sheath 542. In some examples, the handle514 is shaped and sized to approximate the size of the housing 12 of thedevice 10, such that with advancement of at least a portion of thehandle 514 into the patient through an incision creates a subcutaneousor subdermal pocket substantially sized to accommodate the housing 12 ofthe device 10 within the pocket. In this way, insertion of the apparatus500 at least partially within the patient creates a tunnel (forinstance, for the antenna 16 of the device) using the dilator 512 and apocket (for instance, for the housing 12 of the device 10) using thehandle 514. In this way, in some examples, a pocket sized moreaccurately to the size of the housing 12 of the device 10 can becreated, thereby decreasing the possibility of creating animproperly-sized pocket, as is possible when creating the pocket withoutusing a guide. Use of the handle 514 to size the pocket can decrease, ifnot eliminate, creation of an improperly-sized pocket for the housing 12of the device 10 and decrease, if not eliminate, issues associated withan improperly-sized pocket. For instance, too large of a pocket wouldallow migration of the housing 12 and the device 10 within the body,whereas too small of a pocket would require one or more subsequentattempts to enlarge the pocket, which increases procedure time andexpense.

In some examples, the sheath housing 544 and/or the passage of thesheath housing 544 includes a funnel-like configuration to facilitateinsertion of the antenna 16 within the passage and the sheath 542. Insome examples, the passage of the sheath housing 544 includes a funnelshape configured to facilitate insertion of the antenna 16 within asheath lumen 543. In some examples, the sheath portion 540 includes asheath handle 545 or other gripping portion to facilitate grasping,handling, maneuvering, and the like of the sheath portion 540 during useof the sheath portion 540 by the physician or other caregiver.

In some examples, the dilator portion 510 and the sheath portion 540 arefrictionally coupled together, such that the dilator portion 510 and thesheath portion 540 can be selectively uncoupled by a physician or othercaregiver using the apparatus 500. In some examples, the dilator portion510 and the sheath portion 540 include a detent configuration or thelike to inhibit unexpected uncoupling of the dilator portion 510 and thesheath portion 540. In some examples, the dilator portion 510 includesone or more protrusions 519 that interact with one or more dimples 549of the sheath portion 540 to inhibit unexpected uncoupling of thedilator portion 510 and the sheath portion 540. In other examples, otherconnection configurations are contemplated, such as, but not limited to,one or more of a tab-in-slot configuration, a slidable rail-in-slotconfiguration, or the like.

In some examples, the dilator 512 terminates at a distal dilator end512A. In some examples, the distal dilator end 512A includes anatraumatic tip or is otherwise shaped and/or configured to minimizetissue damage or other unwanted effects of using the apparatus 500 tocreate a subcutaneous pocket in which to implant a device, such as thedevice 10. In some examples, the dilator 512 is sized to extend distallyfrom the sheath 542 with the dilator portion 510 and the sheath portion540 coupled together.

In some examples, because the housing 12 and/or header 14 of theimplantable device 10 is larger than the sheath lumen 543, the sheath542 is configured to allow removal of the sheath 542 from within thepatient and past the housing 12 and/or header 14. In some examples, thesheath 542 is splittable with removing of the sheath portion 540 pastthe device 10 (similar to the splittable sheathes 242 described andshown herein). In some examples, pulling the sheath 542 past the housing12 and/or the header 14 of the device 10 separates the sheath 542 andcauses a split 541 to propagate along the sheath 542, as seen in FIGS.5D and 5E. In some examples, the sheath 542 is configured to split, rip,or otherwise separate from a proximal sheath end to a distal sheath endto allow the sheath portion 540 to be removed proximally from thepatient around the housing 12 and/or the header 14 of the implantabledevice 10. In some examples, the sheath 542 is configured to splitsubstantially longitudinally along the sheath 542. In some examples, itis contemplated that the sheath 542 is presplit in a manner similar tothat described above with respect to the presplit sheathes 242′, 242″,342 described and shown herein.

In some examples, the dilator portion 510 includes a receptacle 516 orother surface for interacting with the device 10 to abut at least aportion of the device 10 and aid in pushing the device into the sheathportion 510 and/or the patient and/or holding the device 10 in placewithin the patient during removal of the sheath portion 540 from thepatient. That is, in some examples, once the apparatus 500 is in placewithin the patient so that a tunnel is created by the dilator 512 forthe antenna 16 and a pocket is created by the handle 514 for the housing12, the dilator portion 510 can be removed from the sheath portion 540(FIG. 5B), leaving the sheath portion 540 within the patient. The device10, in some examples, can then be placed within the receptacle 516 orotherwise against a surface of the dilator portion. In some examples,the dilator portion 510 is rotated 180 degrees so that the dilator 512extends generally proximally and the receptacle 516 or other surface forinteracting with the device 10 faces generally distally to accept, abut,or otherwise interact with the device 10 (FIG. 5C). The antenna 16 ofthe device 10, in some examples, can then be inserted within the passage544C and/or the lumen 543 of the sheath 542 and the device 10 can bepushed distally into the sheath 542 and into place in the tunnel andpocket within the patient by distally pushing the dilator portion 510 inthe direction of arrow Y (FIG. 5D). In some examples, the dilatorportion 510, with the receptacle 516 or other surface accepting,abutting, or otherwise interacting with the device 10, can be held tomaintain placement of the device 10 within the patient during removal ofthe sheath portion 540 from within the patient and around the header 14and/or the housing 12 of the device 10. In some examples, the sheathportion 540 can be removed from within the patient by grasping thesheath handle 545 and pulling the sheath portion 540 proximally over andpast the device 10 and the dilator portion 510 in the direction of arrowZ (FIGS. 5D and 5E). Once the sheath portion 540 is removed from withinthe patient, in some examples, the dilator portion 510 can be removedfrom engagement, abutment, or other interaction with the device 10,leaving the device 10 in place within the patient. It is noted that insome examples, the dilator 512 and/or the handle 514 of the dilatorportion 510 can be grasped by the physician or other caregiver in orderto manipulate and/or push the device 10 distally into place and/or holdthe device 10 during removal of the sheath portion 540 from within thepatient. In other examples, the device 10 can be placed within thepatient and held in place during removal of the sheath portion 540 fromthe patient without using the dilator portion 510 and or the receptacle516 of the dilator portion 510.

Referring to FIGS. 6A-6C, in some examples, an apparatus 600 isconfigured for aiding in the subcutaneous implantation within a patientof a device, such as, but not limited to a medical device. In someexamples, the apparatus 600 is configured to create a subcutaneouspocket or other space within the patient in order to implant a device,such as the device 10, within the patient. In some examples, theapparatus 600 can be used to assist in implantation of a device, such asthe device 10.

In some examples, the apparatus 600 includes a dilator portion 610 and asheath portion 640. The dilator portion 610 and the sheath portion 640,in some examples, are configured such that the dilator portion 610 andthe sheath portion 640 selectively couple together, as shown in FIG. 6A.In some examples, a handle 614 includes a portion 618 complementary to apassage 644C of a sheath housing 644 to fit within the passage 644C witha dilator 612 disposed within a sheath 642. In some examples, the sheathhousing 644 and/or the passage of the sheath housing 644 includes afunnel-like configuration to facilitate insertion of the antenna 16 ofthe device 10 within the passage and the sheath 642. In some examples,the passage of the sheath housing 644 includes a funnel shape configuredto facilitate insertion of the antenna 16 within a sheath lumen. In someexamples, the sheath portion 640 includes a sheath handle 645 or othergripping portion to facilitate grasping, handling, maneuvering, and thelike of the sheath portion 640 during use of the sheath portion 640 bythe physician or other caregiver.

In some examples, the dilator portion 610 and the sheath portion 640 arefrictionally coupled together, such that the dilator portion 610 and thesheath portion 640 can be selectively uncoupled by a physician or othercaregiver using the apparatus 600. In some examples, the dilator portion610 and the sheath portion 640 include a detent configuration or thelike to inhibit unexpected uncoupling of the dilator portion 610 and thesheath portion 640. In some examples, the dilator portion 610 includesone or more protrusions 619 that interact with one or more dimples ofthe sheath portion 640 to inhibit unexpected uncoupling of the dilatorportion 610 and the sheath portion 640. In other examples, otherconnection configurations are contemplated, such as, but not limited to,one or more of a tab-in-slot configuration, a slidable rail-in-slotconfiguration, or the like.

In some examples, the dilator 612 terminates at a distal dilator end612A. In some examples, the distal dilator end 612A includes anatraumatic tip or is otherwise shaped and/or configured to minimizetissue damage or other unwanted effects of using the apparatus 600 tocreate a subcutaneous pocket in which to implant a device, such as thedevice 10. In some examples, the dilator 612 is sized to extend distallyfrom the sheath 642 with the dilator portion 610 and the sheath portion640 coupled together.

Because, in some examples, the housing 12 and/or the header 14 of theimplantable device 10 is larger than the sheath lumen, the sheath 642 isconfigured to allow removal of the sheath 642 from within the patientand past the housing 12 and/or header 14. In some examples, the sheath642 is splittable with removing of the sheath portion 640 past thedevice 10 (similar to the splittable sheathes 242 described and shownherein). In some examples, pulling the sheath 642 past the housing 12and/or the header 14 of the device 10 separates the sheath 642 andcauses a split 641 to propagate along the sheath 642, as seen in FIG.6C. In some examples, the sheath 642 is configured to split, rip, orotherwise separate from a proximal sheath end to a distal sheath end toallow the sheath portion 640 to be removed proximally from the patientaround the housing 12 and/or the header 14 of the implantable device 10.In some examples, the sheath 642 is configured to split substantiallylongitudinally along the sheath 642. In some examples, it iscontemplated that the sheath 642 is presplit in a manner similar to thatdescribed above with respect to the presplit sheathes 242′, 242″, 342described and shown herein.

In some examples, one or both of the handle 614 of the dilator portion610 and the sheath handle 645 are formed to mimic handles or graspingportions of another medical or surgical instrument. For instance, insome examples, the handle 614 and the sheath handle 645 mimic the handleof a surgical clamp, forceps, scissors, or the like.

In some examples, once the apparatus 600 is in place within the patient,the dilator portion 610 can be removed from the sheath portion 640 (FIG.6B), leaving the sheath portion 640 within the patient. The antenna 16of the device 10, in some examples, can then be inserted within thepassage 644C and/or the lumen of the sheath 642 and the device 10 can bepushed distally into the sheath 642 and into place within the patient bydistally pushing the device 10 (FIG. 6C). In some examples, the device10 can be held to maintain placement of the device 10 within the patientduring removal of the sheath portion 640 from within the patient andaround the header 14 and/or the housing 12 of the device 10. In someexamples, the sheath portion 640 can be removed from within the patientby grasping the sheath handle 645 and pulling the sheath portion 640proximally (FIG. 6C). Once the sheath portion 640 is removed from withinthe patient, in some examples, the device 10 is left in place within thepatient.

Referring to FIGS. 7A-7C, in some examples, an apparatus 700 isconfigured for aiding in the subcutaneous implantation within a patientof a device, such as, but not limited to a medical device. In someexamples, the apparatus 700 is configured to create a subcutaneouspocket or other space within the patient in order to implant a device,such as the device 10, within the patient. In some examples, theapparatus 700 can be used to assist in implantation of a device, such asthe device 10.

In some examples, the apparatus 700 includes a dilator portion 710 and asheath portion 740. The dilator portion 710 and the sheath portion 740,in some examples, are configured such that the dilator portion 710 andthe sheath portion 740 selectively couple together, as shown in FIG. 7A.In some examples, a handle 714 includes a portion 718 complementary to apassage 744C of a sheath housing 744 to fit within the passage 744C witha dilator 712 disposed within a sheath 742. In some examples, the sheathhousing 744 and/or the passage of the sheath housing 744 includes afunnel-like configuration to facilitate insertion of the antenna 16 ofthe device 10 within the passage and the sheath 742. In some examples,the passage of the sheath housing 744 includes a funnel shape configuredto facilitate insertion of the antenna 16 within a sheath lumen. In someexamples, the sheath portion 740 includes a sheath handle 745 or othergripping portion to facilitate grasping, handling, maneuvering, and thelike of the sheath portion 740 during use of the sheath portion 740 bythe physician or other caregiver.

In some examples, the dilator portion 710 and the sheath portion 740 arefrictionally coupled together, such that the dilator portion 710 and thesheath portion 740 can be selectively uncoupled by a physician or othercaregiver using the apparatus 700. In some examples, one of the dilatorportion 710 and the sheath portion 740 includes a gripping portion 719to inhibit unexpected uncoupling of the dilator portion 710 and thesheath portion 740. In some examples, the dilator portion 710 includes agripping portion 719 sized and shaped to frictionally grip a portion ofthe sheath portion 740 to inhibit unexpected uncoupling of the dilatorportion 710 and the sheath portion 740. In some examples, the grippingportion 719 includes one or more distally-extending fingers 719A to gripthe portion of the sheath housing 744. In some examples, the grippingportion 719 is configured to inhibit distal advancement of the dilatorportion 710 relative to the sheath portion 740 beyond a desired point.In some examples, the dilator portion 710 is inhibited from beingdistally advanced with respect to the sheath portion 740 beyond a pointat which the handle 714 and the sheath handle 745 substantially line up.In other examples, other connection configurations are contemplated,such as, but not limited to, one or more of a detent configuration, atab-in-slot configuration, a slidable rail-in-slot configuration, or thelike.

In some examples, the dilator 712 terminates at a distal dilator end712A. In some examples, the distal dilator end 712A includes anatraumatic tip or is otherwise shaped and/or configured to minimizetissue damage or other unwanted effects of using the apparatus 700 tocreate a subcutaneous pocket in which to implant a device, such as thedevice 10. In some examples, the dilator 712 is sized to extend distallyfrom the sheath 742 with the dilator portion 710 and the sheath portion740 coupled together. In some examples, the gripping portion 719inhibits the dilator portion 710 from being distally advanced withrespect to the sheath portion 740 beyond a point at which the distaldilator end 712A extends just beyond a distal end of the sheath 742.

Because, in some examples, the housing 12 and/or the header 14 of theimplantable device 10 is larger than the sheath lumen, the sheath 742 isconfigured to allow removal of the sheath 742 from within the patientand past the housing 12 and/or header 14. In some examples, the sheath742 is splittable with removing of the sheath portion 740 past thedevice 10 (similar to the splittable sheathes 242 described and shownherein). In some examples, pulling the sheath 742 past the housing 12and/or the header 14 of the device 10 separates the sheath 742 andcauses a split 741 to propagate along the sheath 742, as seen in FIG.7C. In some examples, the sheath 742 is configured to split, rip, orotherwise separate from a proximal sheath end to a distal sheath end toallow the sheath portion 740 to be removed proximally from the patientaround the housing 12 and/or the header 14 of the implantable device 10.In some examples, the sheath 742 is configured to split substantiallylongitudinally along the sheath 742. In some examples, it iscontemplated that the sheath 742 is presplit in a manner similar to thatdescribed above with respect to the presplit sheathes 242′, 242″, 342described and shown herein.

In some examples, one or both of the handle 714 of the dilator portion710 and the sheath handle 745 are formed to mimic handles or graspingportions of another medical or surgical instrument. For instance, insome examples, the handle 714 and the sheath handle 745 mimic the handleof a surgical clamp, forceps, scissors, or the like.

In some examples, once the apparatus 700 is in place within the patient,the dilator portion 710 can be removed from the sheath portion 740 (FIG.7B), leaving the sheath portion 740 within the patient. The antenna 16of the device 10, in some examples, can then be inserted within thepassage 744C and/or the lumen of the sheath 742 and the device 10 can bepushed distally into the sheath 742 and into place within the patient bydistally pushing the device 10 (FIG. 7C), In some examples, the device10 can be held to maintain placement of the device 10 within the patientduring removal of the sheath portion 740 from within the patient andaround the header 14 and/or the housing 12 of the device 10. In someexamples, the sheath portion 740 can be removed from within the patientby grasping the sheath handle 745 and pulling the sheath portion 740proximally. Once the sheath portion 740 is removed from within thepatient, in some examples, the device 10 is left in place within thepatient.

Referring to FIGS. 8A-8C, in some examples, an apparatus 800 isconfigured for aiding in the subcutaneous implantation within a patientof a device, such as, but not limited to a medical device. In someexamples, the apparatus 800 is configured to create a subcutaneouspocket or other space within the patient in order to implant a device,such as the device 10, within the patient. In some examples, theapparatus 800 can be used to assist in implantation of a device, such asthe device 10.

In some examples, the apparatus 800 includes a dilator portion 810 and asheath portion 840. The dilator portion 810 and the sheath portion 840,in some examples, are configured such that the dilator portion 810 andthe sheath portion 840 selectively couple together, as shown in FIG. 8A.In some examples, a handle 814 includes a portion 818 complementary to apassage 844C of a sheath housing 844 to fit within the passage 844C witha dilator 812 disposed within a sheath 842. In some examples, the sheathhousing 844 and/or the passage of the sheath housing 844 includes afunnel-like configuration to facilitate insertion of the antenna 16 ofthe device 10 within the passage and the sheath 842. In some examples,the passage of the sheath housing 844 includes a funnel shape configuredto facilitate insertion of the antenna 16 within a sheath lumen. In someexamples, the sheath portion 840 includes a sheath handle 845 or othergripping portion to facilitate grasping, handling, maneuvering, and thelike of the sheath portion 840 during use of the sheath portion 840 bythe physician or other caregiver.

In some examples, the dilator portion 810 and the sheath portion 840 arefrictionally coupled together, such that the dilator portion 810 and thesheath portion 840 can be selectively uncoupled by a physician or othercaregiver using the apparatus 800. In some examples, one of the dilatorportion 810 and the sheath portion 840 includes a gripping portion 819to inhibit unexpected uncoupling of the dilator portion 810 and thesheath portion 840. In some examples, the dilator portion 810 includes agripping portion 819 sized and shaped to frictionally grip a portion ofthe sheath portion 840 to inhibit unexpected uncoupling of the dilatorportion 810 and the sheath portion 840. In some examples, the grippingportion 819 includes one or more distally-extending fingers 819A to gripthe portion of the sheath housing 844. In some examples, the grippingportion 819 is configured to inhibit distal advancement of the dilatorportion 810 relative to the sheath portion 840 beyond a desired point.In some examples, the dilator portion 810 is inhibited from beingdistally advanced with respect to the sheath portion 840 beyond a pointat which gripping of the handle 814 becomes blocked, obscured, orotherwise made difficult by the sheath handle 845 or another portion ofthe sheath portion 540. In other examples, other connectionconfigurations are contemplated, such as, but not limited to, one ormore of a detent configuration, a tab-in-slot configuration, a slidablerail-in-slot configuration, or the like.

In some examples, the dilator 812 terminates at a distal dilator end812A. In some examples, the distal dilator end 812A includes anatraumatic tip or is otherwise shaped and/or configured to minimizetissue damage or other unwanted effects of using the apparatus 800 tocreate a subcutaneous pocket in which to implant a device, such as thedevice 10. In some examples, the dilator 812 is sized to extend distallyfrom the sheath 842 with the dilator portion 810 and the sheath portion840 coupled together. In some examples, the gripping portion 819inhibits the dilator portion 810 from being distally advanced withrespect to the sheath portion 840 beyond a point at which the distaldilator end 812A extends just beyond a distal end of the sheath 842.

Because, in some examples, the housing 12 and/or the header 14 of theimplantable device 10 is larger than the sheath lumen, the sheath 842 isconfigured to allow removal of the sheath 842 from within the patientand past the housing 12 and/or header 14. In some examples, the sheath842 is splittable with removing of the sheath portion 840 past thedevice 10 (similar to the splittable sheathes 242 described and shownherein). In some examples, pulling the sheath 842 past the housing 12and/or the header 14 of the device 10 separates the sheath 842 andcauses a split 841 to propagate along the sheath 842, as seen in FIG.8C. In some examples, the sheath 842 is configured to split, rip, orotherwise separate from a proximal sheath end to a distal sheath end toallow the sheath portion 840 to be removed proximally from the patientaround the housing 12 and/or the header 14 of the implantable device 10.In some examples, the sheath 842 is configured to split substantiallylongitudinally along the sheath 842. In some examples, it iscontemplated that the sheath 842 is presplit in a manner similar to thatdescribed above with respect to the presplit sheathes 242′, 242″, 342described and shown herein.

In some examples, one or both of the handle 814 of the dilator portion810 and the sheath handle 845 are formed to mimic handles or graspingportions of another medical or surgical instrument. For instance, insome examples, the handle 814 mimics the handle of a tunneling tool orthe like. In some examples, the sheath handle 845 mimics the handle of asurgical clamp, forceps, scissors, or the like.

In some examples, once the apparatus 800 is in place within the patient,the dilator portion 810 can be removed from the sheath portion 840 (FIG.8B), leaving the sheath portion 840 within the patient. The antenna 16of the device 10, in some examples, can then be inserted within thepassage 844C and/or the lumen of the sheath 842 and the device 10 can bepushed distally into the sheath 842 and into place within the patient bydistally pushing the device 10 (FIG. 8C). In some examples, the device10 can be held to maintain placement of the device 10 within the patientduring removal of the sheath portion 740 from within the patient andaround the header 14 and/or the housing 12 of the device 10. In someexamples, the sheath portion 840 can be removed from within the patientby grasping the sheath handle 845 and pulling the sheath portion 840proximally. Once the sheath portion 840 is removed from within thepatient, in some examples, the device 10 is left in place within thepatient.

Referring to FIGS. 9A and 9B, in some examples, apparatuses 900, 900′are configured for aiding in the subcutaneous implantation of a device,such as, but not limited to a medical device, within a patient. In someexamples, the apparatuses 900, 900′ are each configured to create asubcutaneous pocket or other space within the patient in order toimplant a device, such as the device 10, within the patient. In someexamples, the apparatuses 900, 900′ can be used to assist inimplantation of a device, such as the device 10. It is noted that theapparatuses 900, 900′ are similar to the apparatus 200 described herein.That said, the following description and subject matter related toapparatuses 900, 900′ can relate to and be used with any of theapparatuses 200, 300, 400, 500, 600, 700, 800 described herein.

Similar to apparatus 200, in some examples, the apparatus 900, 900′includes a removable dilator portion 910, 910′ removably engageable witha sheath portion 940, 940′. In some examples, the dilator portion 910,910′ includes a dilator 912, 912′ including a distal dilator end 912A,912A′. In some examples, the dilator portion 910, 910′ includes a handle914, 914′ disposed at a proximal end of the dilator portion 910, 910′.In some examples, the sheath portion 940, 940′ includes a sheath housing944, 944′ attached to a proximal end of a sheath 942, 942′. In variousexamples, the sheath 942, 942′ can be configured to be splittable orpresplit, as described herein. In some examples, the apparatus 900, 900′includes electrodes 902, 902′ to sense physiologic signal from and/orstimulate the tissue of the patient, and replicate, or otherwiseapproximate, electrode spacing and placement of the device 10 (FIG. 1).Although shown in FIGS. 9A and 9B with four electrodes 902, 902′, it iscontemplated that, in other examples, the apparatus 900, 900′ includesmore or less than four electrodes 902, 902′.

For instance, in some examples, the apparatus 900, 900′ can include twoelectrodes to sense a physiologic signal from and/or stimulate thetissue of the patient, and replicate, or otherwise approximate,electrode spacing and placement of the device 10. In some examples, theapparatus 900, 900′ includes two electrodes 902A, 902A′, 902B, 902B′disposed on the dilator portion 910, 910′ and spaced apart a distanceE1, E1′, for instance, to simulate, replicate, or otherwise approximateelectrode spacing and placement of the device 10. In other examples, theapparatus 900, 900′ includes two electrodes 902C, 902C′, 902D, 902D′disposed on the sheath portion 940, 940′ and spaced apart a distance E2,E2′, for instance, to simulate, replicate, or otherwise approximateelectrode spacing and placement of the device 10. In still otherexamples, the apparatus 900, 900′ includes the two electrodes 902A,902A′, 902B, 902B′ disposed on the dilator portion 910, 910′ and the twoelectrodes 902C, 902C′, 902D, 902D′ disposed on the sheath portion 940,940′. In other examples, the apparatus 900, 900′ includes more than fourelectrodes disposed at various locations on the dilator portion 910,910′ and/or the sheath portion 940, 940′.

In some examples, the apparatus 900, 900′ includes conductors 904, 904′from the electrodes 902A, 902A′, 902B, 902B′, 902C, 902C′, 902D, 902D′to connectors 906, 906′. In some examples, the connectors 906, 906′ areconfigured to be electrically coupled to an external test device orsignal generator. In some examples, referring briefly to FIG. 9A, theconnectors 906 are male connectors 906 configured to be plugged intofemale connectors of the test device or signal generator or clasped ontowith alligator clips or other clips or attachment devices of the testdevice or signal generator. In some examples, referring briefly to FIG.9B, the connectors 906′ are female connectors 906′ configured to acceptmale connectors of the test device or signal generator. In someexamples, the female connectors 906′ are disposed within a hub 905′ atthe end of the conductor 904′. In some examples, the female connectors906′ are disposed within a hub 915′ disposed within the dilator portion910′ (such as within a proximal end of the handle 914, for instance). Insome examples, the apparatus 900, 900′ can include a combination of maleconnectors and female connectors. In some examples, the apparatus 900′can include connectors disposed within a second hub extending from thedilator portion 910′ (rather than disposed within a hub 915′ disposedwithin the handle 914′) in a manner similar to the hub 905′.

In various examples, the electrodes 902A, 902A′, 902B, 902B′ of thedilator portion 910, 910′ and/or the electrodes 902C, 902C′, 902D, 902D′of the sheath portion 940, 940′ are located and spaced to replicateelectrode spacing and placement of the device 10 to allow the physicianor other caregiver the opportunity to test the implant location for theelectrodes of the device 10 prior to actually implanting the device 10.That is, in some examples, with the apparatus 900, 900′ located at leastpartially within the patient at the desired implant site, the apparatus900, 900′ can be electrically coupled to a test device or other device(for instance, by coupling connectors of the test device to theconnectors 906, 906′ of the apparatus 900, 900′) to verify or otherwisetest or verify a signal at that location within the patient prior toactually implanting the device 10. In this way, the signal can beverified, and, if the test signal is deemed unsatisfactory, thephysician or other caregiver can relocate the apparatus 900, 900′ andtest again until the signal is deemed satisfactory, at which point thedevice 10 can be implanted. This can lessen, if not eliminate, thepossibility of implanting the device 10 in a location and/or positionwithin the patient that produces a weak or otherwise unsatisfactorysignal.

The present inventors have recognized various advantages of the subjectmatter described herein. For instance, in some examples, theapparatuses, systems, and methods described herein can be used tosubcutaneously implant a device. The present inventors have furtherrecognized, among other things, that the present subject matter, invarious examples, can provide a simpler approach to insertion, shorterinsertion time, reduced risk of complications, reduced expense, and/or areduced need for expensive equipment, such as fluoroscopy, during deviceplacement. While various advantages of the example apparatuses, systems,and methods are listed herein, this list is not considered to becomplete, as further advantages may become apparent from the descriptionand figures presented herein.

Although the subject matter of the present patent application has beendescribed with reference to various examples, workers skilled in the artwill recognize that changes can be made in form and detail withoutdeparting from the scope of the subject matter recited in the belowclaims.

The above Detailed Description includes references to the accompanyingdrawings, which form a part of the Detailed Description. The drawingsshow, by way of illustration, specific examples in which the presentapparatuses and methods can be practiced. These embodiments are alsoreferred to herein as “examples.”

The above Detailed Description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreelements thereof) can be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. Also, various features or elementscan be grouped together to streamline the disclosure. This should not beinterpreted as intending that an unclaimed disclosed feature isessential to any claim. Rather, inventive subject matter can lie in lessthan all features of a particular disclosed embodiment. Thus, thefollowing claims are hereby incorporated into the Detailed Description,with each claim standing on its own as a separate embodiment. The scopeof the invention should be determined with reference to the appendedclaims, along with the full scope of equivalents to which such claimsare entitled.

In this document, the terms “a” or “an” are used to include one or morethan one, independent of any other instances or usages of “at least one”or “one or more.” In this document, the term “or” is used to refer to anonexclusive or, such that “A or B” includes “A but not B,” “B but notA,” and “A and B,” unless otherwise indicated. In this document, theterms “about” and “approximately” or similar are used to refer to anamount that is nearly, almost, or in the vicinity of being equal to astated amount.

In the appended claims, the terms “including” and “in which” are used asthe plain-English equivalents of the respective terms “comprising” and“wherein.” Also, in the following claims, the terms “including” and“comprising” are open-ended, that is, an apparatus or method thatincludes elements in addition to those listed after such a term in aclaim are still deemed to fall within the scope of that claim. Moreover,in the following claims, the terms “first,” “second,” and “third,” etc.are used merely as labels, and are not intended to impose numericalrequirements on their objects.

The Abstract is provided to allow the reader to quickly ascertain thenature of the technical disclosure. It is submitted with theunderstanding that it will not be used to interpret or limit the scopeor meaning of the claims.

1. An apparatus for subcutaneously inserting an implantable devicewithin a patient, the implantable device including a housing and anantenna, the antenna including an antenna length, the apparatuscomprising: a dilator portion including a dilator including a dilatorlength, the dilator portion being configured to separate tissue tocreate a subcutaneous pocket within the patient sized and shaped toaccommodate the implantable device within the subcutaneous pocket; and asheath portion including a sheath sized and shaped to accommodate thedilator within a sheath lumen, the sheath configured to accommodate theantenna of the implantable device with the dilator removed from withinthe sheath, wherein the sheath includes a sheath length that is at leastsubstantially as long as the antenna length, the sheath being configuredto separate to allow removal of the sheath around the implantable deviceto remove the sheath from and leave the implantable device within thesubcutaneous pocket within the patient.
 2. The apparatus of claim 1,wherein the dilator portion includes a handle configured to separatetissue to create the subcutaneous pocket, such that: the dilator portionis configured to create a portion of the subcutaneous pocket configuredto accommodate the antenna of the device; and the handle is configuredto create a portion of the subcutaneous pocket configured to accommodatethe housing of the device.
 3. The apparatus of claim 1, wherein thesheath portion includes a sheath housing at a sheath proximal end, thesheath housing including a passage fluidly coupled with the sheathlumen.
 4. The apparatus of claim 3, wherein the dilator portion includesa handle, the handle having a portion complementary to the passage ofthe sheath housing to fit within the passage with the dilator disposedwithin the sheath.
 5. The apparatus of claim 3, wherein the passage ofthe sheath housing includes a funnel shape configured to facilitateinsertion of the antenna within the sheath lumen.
 6. The apparatus ofclaim 3, wherein the sheath housing includes a first material and thesheath includes a second material, the first material being differentthan the second material.
 7. The apparatus of claim 1, wherein thedilator includes a distal dilator end including an atraumatic shape, thedilator length being longer than the sheath length to allow the distaldilator end to extend distally from the sheath.
 8. The apparatus ofclaim 7, comprising at least two electrodes configured to electricallycouple to a test device, the electrodes being configured to verify asignal at a location within the patient prior to implantation of theimplantable device.
 9. The apparatus of claim 1, wherein the sheath isconfigured to split with removal of the sheath over the implantabledevice.
 10. The apparatus of claim 9, wherein the sheath is configuredto split substantially longitudinally along the sheath.
 11. Theapparatus of claim 1, wherein the sheath includes a substantiallylongitudinal split extending from a proximal sheath end to a distalsheath end, wherein the sheath is configured to spread apart along thesplit to allow removal of the sheath past the housing of the implantabledevice.
 12. The apparatus of claim 11, wherein the sheath includes afirst edge and a second edge forming the substantially longitudinalsplit, the first edge being proximate the second edge.
 13. The apparatusof claim 12, wherein the first edge is separated from the second edge bya gap.
 14. The apparatus of claim 12, wherein the first edge abuts thesecond edge.
 15. The apparatus of claim 12, wherein the first edgeoverlaps the second edge.
 16. An apparatus for subcutaneously insertingan implantable device within a patient, the implantable device includinga housing and an antenna, the antenna including an antenna length, theapparatus comprising: a dilator portion including a dilator including adilator length, the dilator portion being configured to separate tissueto create a subcutaneous pocket within the patient sized and shaped toaccommodate the implantable device within the subcutaneous pocket; and asheath portion including: a sheath sized and shaped to accommodate thedilator within a sheath lumen, the sheath configured to accommodate theantenna of the implantable device with the dilator removed from withinthe sheath, wherein the sheath includes a sheath length that is at leastsubstantially as long as the antenna length; and a sheath housingdisposed at a proximal sheath end, the sheath housing including apassage fluidly coupled with the sheath lumen at a sheath housing distalend and extending through the sheath housing to a sheath housingproximal end, the sheath housing including an opening in a sidewall ofthe sheath housing, wherein the sheath is configured to separate along aseparation line substantially aligning with the opening in the sidewallof the sheath housing, the separation line and the opening cooperatingto allow the housing to pass through the opening and the separatedsheath with removal of the sheath from the implantable device to leavethe implantable device within the subcutaneous pocket within thepatient.
 17. The apparatus of claim 16, wherein the sheath is configuredto split with removal of the sheath over the implantable device.
 18. Theapparatus of claim 16, wherein the sheath includes a first edge and asecond edge forming a substantially longitudinal split extending from asheath proximal end to a sheath distal end, wherein the sheath isconfigured to spread apart along the split to allow removal of thesheath past the housing of the implantable device.
 19. The apparatus ofclaim 16, wherein the dilator portion includes a handle configured toseparate tissue to create the subcutaneous pocket, such that: thedilator portion is configured to create a portion of the subcutaneouspocket configured to accommodate the antenna of the device; and thehandle is configured to create a portion of the subcutaneous pocketconfigured to accommodate the housing of the device.
 20. The apparatusof claim 16, comprising at least two electrodes configured toelectrically couple to a test device, the electrodes being configured toverify a signal at a location within the patient prior to implantationof the implantable device.